Japanese partner backs away from plan to seek European approval of drug

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Aveo Pharmaceuticals Inc., already reeling from an advisory panel recommendation early this month that US regulators reject its kidney cancer drug, has suffered a new setback.

In a regulatory filing, the Cambridge biotechnology company told investors its Japanese partner, Astellas Pharma Inc., has pulled out of an agreement to seek approval of the Aveo drug candidate, called tivozanib, in Europe. The drug treats renal cell carcinoma, a type of kidney cancer that kills tens of thousands of people worldwide every year.

While the Food and Drug Administration is expected to rule by July 28 whether to approve Aveo’s capsule for sale in the United States, the Astellas retreat — following a surprise 13-to-1 vote against tivozanib by an FDA advisory committee on May 1 — dimmed prospects for an experimental treatment once regarded as promising for kidney cancer patients.

Shares of Aveo, battered by the advisory panel action, essentially closed flat Friday — edging up a penny to $2.71 on the Nasdaq exchange after trading down most of the day.

Adnan Butt, analyst for RBC Capital Markets in San Francisco, said the Astellas decision does not necessarily spell doom for Aveo’s drug. Butt noted researchers for the Japanese company continue to test its effectiveness in treating colorectal cancer and breast cancer, while other investigators are testing the Aveo capsule as a liver cancer therapy.

“The drug is not dead by any means,” Butt said. “But the question is whether anyone is willing to invest any more money into it as a treatment for kidney cancer. I still think this is a good drug, but a kidney cancer indication may not be the best way to get it onto the market.”

There are at least five other approved drugs to treat renal cell carcinoma in the United States. Though none cure the disease, they all extend — and improve the quality of — patients’ lives.

In a late-stage clinical trial of 517 patients, which compared Aveo’s drug against Nexavar, a treatment comarketed by Onyx Pharmaceuticals Inc. and Bayer HealthCare Pharmaceuticals Inc., tivozanib met its goal of slowing progression of the disease. But patients taking Nexavar had better overall survival rates. Given those results, FDA staffers in April suggested another clinical trial may be needed to weigh the risks and benefits of the Cambridge company’s treatment.

Whether and how Aveo could raise money to fund such a study is unclear. Company vice president Rob Kloppenburg declined to discuss the matter Friday. Officials at the US office of Astellas did not respond to a request for comment.

In its Thursday filing with the Securities and Exchange Commission, Aveo said it was informed by Astellas last week that the Japanese company “no longer intends to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of patients with advanced renal cell carcinoma.” Astellas also said it will not fund any future clinical trials of the compound as a treatment for kidney cancer, according to the filing.

Aveo and Astellas struck a collaboration and licencing agreement in early 2011. Under that pact, the companies were to share responsibility for development and commercialization of tivozanib in North America and Europe. In its filing, Aveo said it is still assessing the impact of Astellas’ pullback from the plan to seek approval in Europe.